Comparing two treatments for heart attack patients with high thrombus burden
Effects of Intracoronary Recombinant Human TNK Tissue-type Plasminogen Activator Versus Tirofiban on Myocardial Perfusion and Clinical Prognosis in Patients With ST-segment Elevation Myocardial Infarction and High Thrombus Burden: a Multicenter, Randomized, Controlled, Single-blind, Non-inferior Study
This study is testing if a new treatment for heart attack patients with a lot of blood clots works as well as an existing treatment and whether it causes more bleeding.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Henan Institute of Cardiovascular Epidemiology Academic / other |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT06769256 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and safety of intracoronary rhTNK-tPA compared to Tirofiban in patients experiencing ST-segment elevation myocardial infarction (STEMI) with a high thrombus burden. The study will enroll 300 participants who will be randomly assigned to receive either treatment. The primary outcome will be assessed through the corrected TIMI frame count after percutaneous coronary intervention (PCI), while major adverse events will be monitored over a one-year follow-up period. The trial seeks to determine if rhTNK-tPA is as effective as Tirofiban and whether it leads to a higher incidence of bleeding events.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who have experienced STEMI within 12 hours and have a high thrombus burden.
Not a fit: Patients with severe comorbidities or contraindications to the treatments being tested may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with STEMI and high thrombus burden, potentially improving outcomes and reducing complications.
How similar studies have performed: Previous studies have explored similar treatment comparisons in STEMI patients, but the specific use of rhTNK-tPA in this context is less common, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-75 years old; * STEMI within 12 hours of onset; * TIMI flow grade 0-2 or TIMI thrombus grade ≥4 after thrombus aspiration or balloon dilation * Radial artery access Exclusion Criteria: * A functional coronary collateral supply (Rentrop grade≥2) to the infarctrelated artery * Known or suspected old myocardial infarction of target vessels * Rescue PCI * Cardiogenic shock * Contraindications to Tirofiban or rhTNK-tPA * Severe hepatic and renal insufficiency (alanine aminotransferase ≥5 upper limit of normal; estimated glomerular filtration rate \<30ml/min/1.73m2, or on dialysis) * Prolonged (\> 10 minutes) cardiopulmonary resuscitation * Definite mechanical complications (including ventricular septal perforation, or rupture of the Papillary tendon bundle, or rupture of the left ventricular free wall) * Severe chronic obstructive pulmonary disease or respiratory failure * Severe infection * Neurological disorders * Malignant tumors or other pathophysiological conditions with an expected survival time of less than 1 year * Pregnant or lactating women
Where this trial is running
Zhengzhou, Henan
- Fuwai Central China Cardiovascular Hospital — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: You Zhang
- Email: 13598019682@126.com
- Phone: +86 37158681037
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.